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NCT Number: NCT07756177

Guangzhou Preterm and Term Birth Cohort Study

The Guangzhou Preterm-Term Birth Cohort (GPTBC) is a prospective observational study of how early-life nutrition, environmental exposures, and family factors relate to the health and development of preterm and term infants and their mothers. Mother-infant pairs are followed from birth to 24 months. Researchers use questionnaires and biological samples to study human milk, microorganisms in the infant gut, physical growth, development, and allergic diseases, and whether these relationships differ between preterm and term infants. Findings may inform nutrition and health strategies for infants born at different gestational ages.

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Key information

Conditions

Preterm Birth Allergic Diseases Body Weight Female Urogenital Diseases and Pregnancy Complications Mental Disorders Neurodevelopmental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obstetric Labor Complications Obstetric Labor, Premature Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

About this study

The Guangzhou Preterm-Term Birth Cohort (GPTBC) is a single-center, prospective longitudinal observational study conducted at the Third Affiliated Hospital of Guangzhou Medical University. Mothers and their preterm or term infants were enrolled within 7 days after delivery and are followed primarily through 24 months of age; a subset receives additional follow-up beyond 24 months. The cohort was designed to recruit approximately equal numbers of preterm and term infants to characterize early-life exposures and health trajectories and to assess whether preterm birth modifies exposure-outcome associations.

The primary scientific focus is how human milk composition and other early-life nutritional and environmental exposures relate to infant growth, neuropsychological development, allergic diseases, and gut microbiome development. Serial human milk samples support measurements of nutritional components, 23 targeted human milk oligosaccharides, selected bioactive proteins, fatty acids, metabolomic and lipidomic profiles, microbial metagenomes, and exposomic profiles of environmental contaminants. Infant stool samples are analyzed using metagenomic sequencing. Additional stored biospecimens support related current and future research.

Repeated questionnaires capture maternal postpartum health, diet, lifestyle, psychological status, medication use, and breastfeeding; infant feeding, supplementation, illness, medication use, sleep, activity, screen exposure, and caregiving environment; and selected paternal and family characteristics. Child health is assessed longitudinally using anthropometry, standardized developmental assessments, eye tracking, parental reports of physician-diagnosed allergic diseases, and microbiome measures.

The study will examine exposure patterns and their changes over time, associations with maternal and child health, potential biological pathways, and differences between preterm and term infants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Maternal age between 18 and 45 years.
  • Resident in Guangzhou for at least one year.
  • Gestational age at delivery ≥ 32 weeks and < 42 weeks (moderate-to-late preterm or term births).

Exclusion criteria

  • Critical illness during pregnancy requiring admission to the intensive care unit.
  • Unwilling or unable to breastfeed.

Treatment and study plan

No Intervention: Observational Cohort

Other

This cohort study have any no intervention.

Primary outcomes

  1. Offspring Length/Height (cm)

    Time frame: Birth, 1 months, 3 months, 6 months, 8 months, 12 months, 18 months, and 24 months of age.

    Offspring length or height measured by a pediatrician.

  2. Offspring Weight (kg)

    Time frame: Birth, 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.

    Offspring weight measured using a calibrated scale.

  3. Offspring Head Circumference (cm)

    Time frame: Birth, 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.

    Offspring head circumference measured by a pediatrician.

  4. Offspring Body Mass Index (kg/m²)

    Time frame: Birth, 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.

    Calculated as weight (kg) divided by the square of length or height (in meters).

  5. Neurodevelopmental outcome - Gesell Developmental Schedules (GDS)

    Time frame: 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, and 24 months of age.

    Developmental Quotients (DQ) for each developmental domain, assessed by the Gesell Developmental Schedules (GDS) administered by a pediatrician. DQ is calculated as (developmental age / chronological age or corrected age) × 100, with higher DQ indicating better development. Domains include: (1) adaptive, (2) gross motor, (3) fine motor, (4) language, and (5) personal-social.

  6. Neurodevelopmental outcome - Ages and Stages Questionnaires (ASQ)

    Time frame: 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.

    Parent-reported scores (0-60) for each developmental domain, assessed using the Ages and Stages Questionnaires (ASQ). Higher scores indicate better development. Domains include: (1) communication, (2) gross motor, (3) fine motor, (4) problem-solving, and (5) personal-social.

Secondary outcomes

  1. Social Cognitive Attention Patterns - Sufficient Fixation Trials (number)

    Time frame: 6 months, 8 months, and 12 months of age.

    Number of trials in which the fixation duration on specific Areas of Interest (social and non-social) exceeds 30% of the total fixation duration on the entire screen, measured using a Tobii Pro Spectrum eye-tracker across biological motion, joint attention, and visual preference paradigms. This eye-tracking indicator indicates adequate attentional engagement with the presented social and non-social stimuli.

  2. Social Cognitive Attention Patterns - First Fixation Count (number)

    Time frame: 6 months, 8 months, 12 months of age.

    Number of times the first fixation following stimuli onset lands on specific Areas of Interest (social and non-social), measured using a Tobii Pro Spectrum eye-tracker across biological motion, joint attention, and visual preference paradigms. This eye-tracking indicator captures initial attentional orienting and reflects the salience of the presented social and non-social stimuli.

  3. Social Cognitive Attention Patterns - First Fixation Duration (seconds)

    Time frame: 6 months, 8 months, 12 months of age.

    Duration (in seconds) of the first fixation within specific Areas of Interest (social and non-social) following stimulus onset, measured using a Tobii Pro Spectrum eye-tracker across biological motion, joint attention, and visual preference paradigms. This eye-tracking indicator reflects early-stage attentional processing and the efficiency of initial stimulus engagement.

  4. Social Cognitive Attention Patterns - Total Fixation Count (number)

    Time frame: 6 months, 8 months, 12 months of age.

    Total number of discrete fixation events occurring within specific Areas of Interest (social and non-social), measured using a Tobii Pro Spectrum eye-tracker across biological motion, joint attention, and visual preference paradigms. This eye-tracking indicator reflects the overall frequency of attentional engagement with the presented social and non-social stimuli.

  5. Social Cognitive Attention Patterns - Total Fixation Duration (seconds)

    Time frame: 6 months, 8 months, 12 months of age.

    Cumulative duration (in seconds) of all fixations occurring within specific Areas of Interest (social and non-social), measured using a Tobii Pro Spectrum eye-tracker across biological motion, joint attention, and visual preference paradigms. This eye-tracking indicator reflects overall attentional allocation to the presented social and non-social stimuli.

  6. Social Cognitive Attention Patterns - Fixation Duration Proportion (%)

    Time frame: 6 months, 8 months, 12 months of age.

    Percentage of total fixation time allocated to social or non-social Areas of Interest, calculated as (total fixation time on social or non-social Areas of Interest / total fixation time on all Areas of Interest) × 100, measured using a Tobii Pro Spectrum eye-tracker across biological motion, joint attention, and visual preference paradigms. This eye-tracking indicator reflects relative attentional preference between social and non-social stimuli.

  7. Number of Participants with Physician-Diagnosed Allergic Diseases

    Time frame: 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.

    Number of participants who experience at least one episode of physician-diagnosed allergic diseases during the follow-up period, including eczema or atopic dermatitis, cow's milk protein allergy, other food allergies, allergic rhinitis, and asthma, as diagnosed by a physician and reported by parents, and confirmed by medical records.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • The Third Affiliated Hospital of Guangzhou Medical University

Registry information

Acronym: GPTBC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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